Orthotics brace and system

ABSTRACT

The present invention relates to medical devices and more particularly to medical devices for joint, bone, and tissue support. A brace system is disclosed incorporating at least two shells placed around an ankle and foot area, with straps and laces. The inner boot incorporates a lace-up removable, molded inner boot. The outer boot includes straps for securing the outer boot to the inner boot and for providing targeted support areas for orthotic purposes.

BACKGROUND OF THE INVENTION

The specialty of orthotics focuses on the design and application ofexternally applied devices used to modify or maintain structural andfunctional characteristics of the neuromuscular and skeletal system. Anorthosis may be used to control guide, or immobilize extremities,joints, or body segments, assist in movement, reduce weight bearingforce, aid rehabilitation, correct shape or function, reduce pain, aidperformance, or other uses.

In the field of lower-limb orthoses, external devices are applied tolower-body segments to, for example, control motion, provide support,stabilize, reduce pain through transferring load to another area,correct flexible deformities, and preventing progression of deformities.Frequently, orthoses are used for foot or ankle conditions or for aid.

Foot orthotics are devices inserted into shoes, around shoes, as areplacement of shoes, or the like, to provide support for the foot byredistributing ground reaction forces acting on the foot joints whilestanding, walking, running, or while immobile. They may be eitherpre-molded or prefabricated or customized with an impression of thefoot. Orthotics may impact not just foot or knee problems, but also hip,spine, and other medical conditions. Proper use may aid athletes, theelderly, or others for skeletal or, for example, soft tissue conditions.Custom-made foot orthoses are effective at reducing pain for peoplewith, for example, painful high-arched feet, fractures or breaks, andmay be effective for people with rheumatoid arthritis, plantar fasciitisor hallux valgus (commonly called bunions), and many other conditions.For children with juvenile idiopathic arthritis (JIA), custom-made andprefabricated foot orthoses may also reduce foot pain. Foot orthoses mayalso be used in conjunction with properly fitted orthopedic footwear inthe prevention of foot ulcers in the at-risk diabetic foot patient.

Orthotics may also be used for ulcer healing purposes. A custom-madeankle/foot orthosis for the treatment of patients having plantar ulcersis disclosed may incorporate elements of a rigid. L-shaped supportmember and a rigid anterior support shell hingedly articulated to theL-shaped support member. The plantar portion of the L-shaped member mayfurther comprise at least one ulcer-protecting hollow spatially locatedfor fitted placement in inferior adjacency to a user's plantar ulcer,thus allowing the user to transfer the user's weight away from theplantar ulcer and facilitating plantar ulcer treatment. The anteriorsupport shell is designed for lateral hinged attachment to the L-shapedmember to take advantage of medial tibial flare structure for enhancing;the weight-bearing properties of the disclosed orthosis. A flexible,polyethylene hinge member hingedly attaches the anterior support shellto the L-shaped member and securing straps securely attach the anteriorsupport shell in fixed, weight-bearing relation about the proximal,anterior portion of the user's lower leg.

Prophylactic braces are used primarily by athletes participating incontact sports. Evidence about prophylactic knee braces, the onesfootball linemen wear that are often rigid with a knee hinge, indicatesthey are ineffective in reducing anterior cruciate ligament tears, butmay be helpful in resisting medial and lateral collateral ligament,tears.

Functional braces are designed for use by people who have alreadyexperienced a knee injury and need support to recover from it. They arealso indicated to help people who are suffering from pain associatedwith arthritis. They are intended to reduce the rotation of the knee andsupport stability, They reduce the chance of hyperextension and increasethe agility and strength of the knee. The majority of these are made ofelastic. They are the least expensive of all braces and are easily foundin a variety of sizes.

Rehabilitation braces are used to limit the movement of the knee in bothmedial and lateral directions—these braces often have an adjustablerange of motion stop potential for limiting flexion and extensionfollowing ACL reconstruction. They are primarily used after injury orsurgery to immobilize the leg. They are larger in size than otherbraces, due to their function.

An ankle-foot orthosis (AFO) is an orthosis or brace that encumbers theankle and foot. AFOs are externally applied and intended to controlposition and motion of the ankle, compensate for weakness, or correctdeformities. AFOs can be used to support weak limbs, or to position alimb with contracted muscles into a more normal position. They are alsoused to immobilize the ankle and lower leg in the presence of arthritisor fracture, and to correct foot drop; an AFO may also be called afoot-drop brace. The base cost of an AFO is often expensive due tonumerous factors, both due to manufacturing costs and due to changingpatient characteristics. An AFO is generally constructed of lightweightpolypropylene-based plastic with the upright portion behind the calf andthe lower portion running under the foot.

Obtaining a good fit with an AFO typically involves two approaches.First, professionals may use an off-the-shelf or prefabricated AFOmatched in size to the end user. Second, professionals may make a custommanufacture of an individualized AFO from a positive model, obtainedfrom a negative cast or the use of computer-aided imaging, design, andmilling. Plastics used to create a durable AFO must typically be heatedto high temperatures, making direct molding of the material on the enduser impossible.

Four major types of AFOs are flexible AFOs, anti-talus AFOs, rigid AFOs,and Tamarack Flexure Joint AFOs.

To stop or limit or assist knee or ankle motion, a knee-ankle-footorthosis (KAFO) may function in one or all the three planes of motion ina human joint: sagittal, coronal, and axial. Mechanical hinges, as wellas electrically controlled hinges have been used. Various materials forfabrication of a KAFO include but are not limited to metals, plastics,fabrics, and leather. Conditions that might benefit from the use of aKAM include paralysis, joint laxity or arthritis, fracture, and others.Although not as widely used as knee orthoses, KAFOs can make a realdifference in the life of a paralyzed person, helping them to walk.These devices are expensive and require maintenance.

SUMMARY OF THE INVENTION

The present invention relates to the fabrication of orthotic devices,for example devices for securing to a patient's foot or leg. Suchdevices may be used to maintain constant pressure against the foot, soleand ankle of the patient for therapeutic purposes, but also for arm,wrist, torso, or other purposes, to include purposes both therapeuticand athletic.

Some prior art devices of provide for leg, ankle and foot stabilizationusing assemblies interconnected by hinges of an elastomeric material ortwo or more shells affixed to one another to form a single brace in whatis commonly referred to in the industry as an “Arizona brace.” AnArizona brace generally contains a plastic shell made of polypropylene,and leather boot affixed thereto. The Arizona Brace is prescribed tostabilize the ankle, talocalcaneal, midtarsal and subtalar joints.Inside a plastic shell, such a brace has a glued plastizote layer, whichis a soft foam, and affixed to that, a mold of a patient's foot, and tothat, additional glued layer of leather. An outer leather layer oftenexists, as well, with the entire product creating one solid unit.

In embodiments of the present invention, an unbroken “L” shape composedof at least two shells provides flexibility of use in combination withrigidity, while other designs (with a jointed ankle) provide differenttypes of control. No leather is required for any shell, nor is itdesired for comfort or medical purposes.

Instead of leather, embodiments of the invention include an orthoticfoot brace having an at least two leg or foot components, non-adjustablein fit but adjustable in rigidity of hook and loop fastener tautness andlacing, and straps for security, support, and also options for patientcompliance, cleanability, and wearability in multiple practicalsituations.

Embodiments of the instant invention include two separate and separablebrace components for use by patients. The molding of an inner braceprevents adjustments, defects, or wrinkles. Use of non-fabric materialsto create the brace further reduces the risk of discomfort and healthproblems related to wear of a fabric-based product. The mold allows forsetting any angular inclination in the mold. Fabric foot and legengagement straps may be used to attach the two separate components ofthe mold to one another. A securing apparatus allows for limited plantarflexion and dorsiflexion of the foot portion of the sagittal plane bythe hinge assembly that can be locked at any point within the sagittalplane range of movement.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front perspective view of an embodiment wherein theembodiment is strapped and laced.

FIG. 2A is a perspective view of an embodiment of an inner shell thatfits inside of the outer shell in FIG. 2B.

FIG. 2B is a perspective view of an embodiment of an outer shell thatreceives the inner shell in FIG. 2A.

FIG. 3 is a side view of an embodiment of the invention wherein theinner shell is secured within the outer shell which is also secured.

FIG. 4 is a perspective view of an embodiment of the invention, wherethe embodiment is created to reach a mid-ankle height, secured as aKAFO.

DETAILED DESCRIPTION OF THE INVENTION

An embodiment of the present invention is directed to an ankle-footorthotic for applying a secure, two-shell support system to allow awearer to conduct activities, to adapt to multiple scenarios at home, atwork, or in more taxing physical situations, while promoting patientwear compliance through wearability, cleanability, and comfort features.

An ankle-foot orthotic embodiment of this invention for treatingmultiple medical conditions or deformities generally comprises at leasttwo shells forming an ankle and lower-leg brace, one shell beinginserted into the other. Embodiments feature highly customizablefittings for each shell due to molding properties of insert fabricationmaterials. Duraflex molding material or a similar product is usuallyheated to approximately 325 degrees for two minutes before it becomesmalleable to shape around the relevant portion of the patient's anatomy.The mold may be placed in the oven for approximately two minutes,removed while hot with welding or similar gloves, draped over a positivemold of a leg, then vacuumed to the positive mold of leg, then 7-10 minharden, then cuts are made. This creates embodiments for a molded innerboot part.

The outer shell of embodiments is comprised of copolymer orpolypropylene or other similar type of plastic, heated to approximately400 degrees Fahrenheit until sufficiently hot, draped over positivepatient mold, let sit for 1 hour to mature, then after an hour the moldis cut and modified. The outer mold is then placed over the positiveBoth materials are approximately ⅛ inch thick. Both are truly custommolded to the patient's anatomy. The copolymer may be a mix ofpolypropylene and ethylene, where the copolymer is frequently harderthan polypropylene. Embodiments may create the outer shell by way ofheating the shell at 400 degrees F. for 3 min to 5 min, depending on themix of plastic, making it harder or softer.

Embodiments may include an at least one mid- to high-ankle strap forhorizontal circumferential security of the outer shell around the innershell, for support, for stabilization, and for other features.Embodiments may also include an at least one second strap that followsbelow the foot arch, across the midfoot to anterior ankle area, andsecures circumferentially at a horizontal plane above the lateral tomedial ankle area.

An embodiment of the invention will now be described. As shown in FIG.1, an inner immobilizing shell 1 is located within an outer immobilizingshell. An ankle support strap 3 may be affixed to one side of the upperankle area of the outer shell, for example with a button, snap, rivet 8,for withstanding high tension as on a medical immobilizing garment. Asecond cross strap is affixed to the outer shell and is used to windabout the outer shell to provide comfort and medically enough supportabout the necessary areas. For example, in FIG. 1, the second strap 4proceeds from the midfoot or mid-ankle area to the posterior of theankle in a horizontal plane, continues to the opposite side of the sameplane, to an area across the gap in the outer shell, and then the secondstrap proceeds across the area approximately between the lower midfootand Lisfranc's Joint areas, underneath the middle of the sole to providesupport to the lateral plantar, medial planter, and saphenous areas,with some added support to the tibial and sural areas. The strap thenproceeds back across the area between the midfoot and Lisfranc's Jointareas and affixes, for example with hook and loop fasteners, atapproximately the area where the strap began. Embodiments of theinvention will have medial ankle 7 and heel sections removed for theless rigid inner boot component to flex in those areas. The top strap 3functions to hold the exterior frame onto the interior frame.

In embodiments, the outer shell will be comprised of cleanable plasticmaterial, where soap and water may remove any debris, dirt, sweat, orother human or clothing waste, odor, smells.

Optionally, and for temporary, minimal activity evolutions, a patient orwearer may only use the inner boot, for example for at home, nearlysedentary activity. The outer shell (FIG. 2B) may be then used foroutdoor activity of whatever kind applicable. The unit, together, may beof such a fit as to be supportive and secure for medical purposes, butalso, due to the materials, the fit, and the compact nature, able to fitinto a wearer's normal as to be able to be worn in footwear typical forthe patient.

Alternative embodiments of the invention include but are not limited touse of more than two shells, a high-ankle or higher orthotic, alow-ankle or lower orthotic, wrist, upper body, lower body, knees,ankles, or, hips, for example, where a mold would be used of the trunkof the body. For example, for a custom mold for the wrist, the cast moldof the positive would be created, the above descriptions applicable tothe pour, modifying processes, placing Duraflex or similar materials inan applicable heating system or oven, making an inner liner, placing thecopolymer in a heating system or oven, providing a molded product for apatient's use. The result is a waterproof, removeable, cleanableproduct, with replacement parts available. The resulting product can beused to safeguard, secure, brace, and/or aid in the healing of problemsincluding the spinal, back, sprains, strains, ligament or tendonconcerns, all fractures, and other roles.

Still additional benefits exist. For example, benefits over the morestandard and commonly used Arizona brace are that the instant inventiondoes not result in stretches of the unit, which can create problems forolder patents, for example with diabetic patients, which can developinto units that have wrinkles. If, for example, a wrinkle, tear, ripple,or other deformity in the leather impacts a diabetic ulcer, there is apossibility of not only further irritation that could preclude use ofthe orthotic brace, but even loss of a leg. This is a distinguishingfeature from embodiments of the instant invention, which does not createopportunities as with leather for wrinkles or other deformities.Embodiments of this invention promote total contact between the orthoticand the patient. Embodiments of the instant invention minimize risk ofslippage or of migration.

As an example of a current used brace, the industry's Arizona brace isfrequently comprised of a plastic shell, typically polypropylene, andinside the plastic shell a soft foam material is glued, and over thesoft foam material is glued leather, forming one solid unit. Embodimentsof the invention, due to not only support but total contact and truecircumferential support, may be used for medial lateral support, planterdorsi support, circumferential compression support and other supportrequirements for many conditions, including but not limited toconsequences of posterior tibial tendon dysfunction, talocalcaneal varusor valgus, charcot foot, severe pronation of planus, chronic achillestendonitis, tibialis tendonitis (posterior or anterior), ankle arthritisor degenerative joint disease, ankle, suntalar, midtarsal trauma, dropfoot, certain symptoms of certain forms of cancer, chronic ankleinstability, post fracture of the distal tibia or fibula, post fracturesof the distal tibia or fibula, post fractures of the ankle, subtalar andmidtarsal trauma, osteoarthritis of the ankle and/or foot, and otherconditions.

In addition to properties of flex and cleanability, embodiments of theorthotic brace system may employ a Duraflex or similar material whichmay incorporate properties of forming a mold that provides total or neartotal contact to the patient's anatomy, or likewise emphasizing acomfortable supporting mold that takes shape of each individual'sanatomy while being flexible and soft to not cause abrasion, soreness(due to flexibility), and allowing the firmer copolymer outer shell toprovide the requisite support and rigidity that would otherwise createabrasion, soreness, redness, irritation, etc., of patient's anatomy.

According to an embodiment of the present invention, the elastic strapmay be the outer shell to be wrapped in a crossing loop taking theapproximate shape represented in FIGS. 1 and 4, where the second strapcrosses the midfoot or Lisfranc's Joint area, proceeding around themedial, middle, and lateral arches, and back to the mid- to low-anklearea. In embodiments, the strap is angled at several ideal angles toprovide the correct tension force for maintaining security of the braceand the support and rigidity to the outer shell and thereby to thepatient.

Additional modifications to embodiments of the brace system may becost-effectively made, despite major changes to patient biologycharacteristics. For example, if a modification is needed due to amedical condition, the straps may be removed, shells may be removed, andthe outer or inner shell may be modified. An example would be tooptionally cut out the lateral and medial malleoli from the outer shell,the malleolus ankle bone, or the heel. See FIG. 1. The outer shell canbe custom modified to all patient's concerns regarding pressure,soreness, incision cites, ulceration, etc. Therefore, other embodimentsare available, to include trimming edges to reduce contact areas asneeded. To the extent additional modification is required, for exampledue to weight loss or other conditions or developments, the plastics ofthe outer shell is heat moldable, which is not an available modificationoption with the Arizona brace.

Concerning hygiene, a typical Arizona brace may take on odor. It may getdirty through normal daily use, and cleanliness is a difficulty thatimpacts wearability and patient compliance. Embodiments of the instantinvention are comprised of hypoallergenic materials, so soapy waterapplications or similarly accessible options may be used to wipe awayodors or other conditions and restore the brace system for clean use.Due to the brace being waterproof (except for option of laces which mayhold water) the patient may use embodiments of the brace system in theshower, the pool, or during aqua therapy, travelling to the beach, orany other circumstance where water may be applicable. New, dry laces arean option for the system to ensure the system is as waterproof and dryas possible.

Optionally, wearers may apply the device without the rigid shell whereconsistent, 100% support is not required, but only 60% to 70% forrelevant low-stress activities. As an example, this inner shell may beworn inside a bedroom slipper or house footwear to allow for increasedpatient compliance over and above industry standard products, such as anArizona brace which many patients find to be too bulky, potentiallyodorous after a period of time, and which may not fit into housefootwear due to bulk.

Regarding potential problems with a patient's navicular bone (medialside of foot, for collapsed midfoot, pronation, etc.), for example aprominent navicular bone or other areas of discomfort, the shells may bemodified accordingly. If the navicular bone is prominent, the brace maybe modified by taking the relevant area of the brace's outer shell andcutting it out, as with cutting out the medial lateral ankle as shown inFIG. 1 Similar options exist where patients need pressure area relief,such as incisions being required due to prior or recent surgeries, archcollapse, and other conditions, deformities, and temporary orlong-lasting ailments, complaints, or other medical- or athletic-relatedconcerns.

Regarding long-lasting conditions, other custom molded products, such asAFOs or other casts, may eventually lead to atrophy. The cast becomestoo big large, potentially lacking the support and brace system that thepatient's anatomy required. The patient's anatomy may slide in a typicalbrace system, such as an Arizona brace, or swelling may lead toinaccurate fits in such products. With embodiments of the instantinvention, however, if atrophying occurs after, for example, six toeight weeks of use, the user may tighten up the laces, or a modest five-to fifteen minute adjustment modification may occur to allow for a morecustom fit for the swelling or atrophying, reducing or eliminatingirritation, slippage and migration, and allowing the patient to recoverproper support.

In embodiments, the securing or fastening of the boot is not the solemeans of supplying support. Fastening the straps, which in embodimentsmay follow different patterns, provide specific, consistent support, forexample for posterior tibial tendon disfunction PTTD. In mostembodiments, whether for foot or ankle or other parts of the body,benefits are often due to characteristics of being form fitting,providing total contact, providing a comfortable snug fit, reducing oreliminating slippage, and resulting in total immobilization. Further,depending on the specific user's needs, Embodiments may also incorporatean above-ankle strap, to support and control ankle instabilities, andprevent slippage or migration and anterior rotating.

While this may apply for PTTD, the brace system provides for solutionsto Achilles tendonitis, Achilles bursitis, Achilles tears, nondisplacedfractures, and other conditions noted above, plus additional conditionsor therapeutic scenarios, to include athletic support. The invention isnot limited to embodiments that support and control hindfoot andmidfoot, nor even limited to support for anti-pronation, and arch foruplift at the relevant tendon and bony structure areas alone.

In addition to providing advantages over typically braces that provide arigid plastic with foam liner that results in an abrasive, non-moldable,non-malleable liner, embodiments of the instant invention also solve anissue that some patients have with negative pressure. Negative pressureis a problem where, for example for a wrist styloid bone, with prominentstyloid, we can modify device to not have any negative pressure due tocutouts. This may be equally applicable for a protrusion at the ankle.

Typically, products are sewn or laminated together, leaving very littleroom for modification after weight loss or weight gain by a patient, orfor latent protrusions leading to negative pressure. For embodiments ofthe invention, if a patient loses, for example, one-half of an inch toan inch in circumference, embodiments can be modified with a scissors, arazor knife tool, to cut down or cut away relevant areas, possiblycreating islands of material. Distinguishing from other devices, if oneneeded to make something smaller down the road for a patient two years,three years, five years due to patient anatomy, weight gain or weightloss, modifications to a new brace provide patients and wearers an orderof merit of cost effectiveness, for example what could be modified ormade at a minimal cost of approximately $150 is a clearly better choicefor most wearers and patients than a new brace at $1,800.

Embodiments of the invention may have with a thickness of outer 1 andinner 2 shells, together, of approximately 4 to 4.5 mm or less at themid-ankle or lower-ankle area. However, for different purposes, thethickness may be widened, as will be discussed below.

It is not uncommon for orthotics patients to seek assistance after aperiod due to an irritation. Embodiments of the instant invention, basedin part on materials and based in part on architecture of the system,have reduced risk of irritation. See above discussion of leather,ripples, and tears. However, if an irritation does arise, typicallybecause of a patient or wearer's anatomical change, a modification maybe made to the brace system. Unlike re-upholstering bulky leathercomponents, where the leather wears away,

It is not uncommon for patients to ask if a leather-molded product canbe “patched” like clothing. This is not provided because a patch canwear away, tear, ripple, or develop an inconsistency that createsfurther problems for the patient.

It is not cost-effective for the patient to make multiple modificationsand adjustments or repairs with an Arizona brace. The instant inventionovercomes this issue for the reasons given and those apparent to thosehaving ordinary skill in the art. Typically, the way other orthotics arecleaned is with leather cleaner or shoe polish, which do not result inthe relatively odorless and cleaner product as with cleaning embodimentsof the instant invention with soapy water, not to mention the ability tothoroughly dry the instant embodiments.

The only thing that would have to replace, for example after 18 monthsor 24 months, is a strap or new laces, which carry minimal cost comparedto the cost of embodiments of the invention. Notably, embodiments mayincorporate hook and loop fasteners instead of laces (see FIG. 1). Forexample, for some patients, such as arthritic patients or diabetics,hook and loop fasteners are preferred, and this element increasescompliance and therefore overall health. The same remedy of hook andloop fasteners instead of laces may also apply with patients who areobese, have back or other problems, and where securing with overlappingstraps best allows for patient compliance. For still other embodiments,for example a wrist embodiment, a preferred embodiment may be one wherean inner, removeable flex shell exists and where only the outer shellhas the strapping, whether laces or hook and loop fasteners.

Further, the soft flexible dorsiflex material of the inner shell notonly provides flexibility but also ameliorates what in other objectswould become areas of irritation. Additionally, if a given patientwithin, for example, six to eight months has another surgery or if amedical condition worsens, embodiments of the instant invention aremodifiable. Orthotics professionals can take the inner or the outerportion of the device and modify the module to conform to that patient'snew requirements, which may be related to injury, weight loss, weightgain, or other concerns or issues. There may be no need to re-form amold or module component or even make a new cast. In some circumstances,the orthotics professional can cut away portions of the old modules ormoldings.

To fabricate embodiments, a drill press may be used to secure hook andloop fastener straps to shell(s) of a brace, for example using stainlesssteel rivets. Sanding cones may be applied in three different forms. Oneis coarse, one is non-coarse, one is for finishing. The outer shellreceives the coarse sanding cone to modify and shape the trimlines tocustom fit the positive mold. Next, the finer cone is used smooth theshell along the edges. Then a finishing cone is used on all the edges toeliminate irritation against the skin. A drill press may be used toprovide eyelets (e.g., brass) for laces. Brass may be used so theeyelets do not rust.

For modifications with common braces used today, an orthoticsprofessional would need to remake the brace, requiring removing both theinner and outer layers of leather, and then remolding the structure, ifsuch a redo can be done. This requires tearing down the entire brace andessentially starting over, and later redoing the leather. Instead ofsuch obstacles, which combine to prevent patient compliance,combinations of characteristics of embodiments of this inventionincentivize use of the system by the patient, such as due towash-ability, cleanability, form-holding and lasting comfort fit,odor-lessness, support strap placement, or other characteristics.

Additional options for embodiments of the invention include but are notlimited to a height brace for posterior tibial tendinitis dysfunction orfor collapse of mid foot forming a flat foot, which provides benefitswhere bones and arteries start to deteriorate. A higher brace willsuffice to support those conditions from the ankle down. With a patientwho had a stroke, or drop foot, skiing fracture of tibia or fibula, forexample just above the ankle, then the brace may be made approximately16-18 inches high, for a typical patient. The required height may behigher or lower and will result in the brace capturing and supportingthe tibia or fibula and the higher the brace extends, the more leverageat the foot.

If a patient has drop foot from back injury, stroke, nerve injury, andcreates drop foot, embodiment will likely be created by casting apatient's mold at an approximately 90-degree angle, so that every stepthe patient takes is automatically heel strike. Alternatively, for someconditions, such as a fractured heel, the mold may be formed so that theno heel strike is automatic. Embodiments may incorporate modificationsof the mold after taking patient cast to customize in a swing phase toallow for the strike at the midfoot, never putting pressure on the heel.

For purposes of clarity, drop foot and other relevant conditions mayresult from spinal cord injury or other accident, or stroke; drop footis the condition where no control of dorsiflexion, or lifting foot ortoes. Other embodiments may aid patients dealing with dragging toe,which could lead to a trip, a fall on shoulder, face, etc., and otherpredetermined configurations. For example, if embodiments are made fordrop foot only nine inches above the floor the 4.9 inches with a footwanting to plant, the top edge of this brace may cut into the lane andthen we come over the gash rocks that an inch below the fibula head. Theresult is extra leverage to hold the foot up more in a dorsiflexposition. Alternative embodiments may incorporate a thin plastic, suchas a polypropylene polyethylene, which is not a dorsiflex material. Withsuch modifications, the brace aids patient compliance by producing theproduct at a faster rate, in addition to the other factors, such ascomfort, flexibility, ease of wear, open front with lacing, ease ofcleaning, modifiability of the brace if the patient loses circumference,etc.

Regarding use of the brace for athletic support, the brace mayincorporate an outer shell of larger width, for example 5/32 inches,3/16 inches, ¼ inches, ⅜ inches, or ½ inches. For example, for aprofessional contact sport, an athlete with a stressed or strainedAchilles tendon can employ a brace that limits dorsiflexion and planarflexion of foot, which limits extension of Achilles tendon duringactivities. Alternatively, if the forearm is a location of a condition,for example at the radius and ulna, where one is fractured and a cast isnot preferable, a brace system may be used instead.

Having described and illustrated the principles of the invention throughthe descriptions of various embodiments thereof, it will be readilyapparent to those skilled in the art that the invention can be modifiedin arrangement and detail without departing from such principles. Theclaims should be interpreted to cover all such variations andmodifications.

I claim:
 1. A system to form a custom therapeutic brace for use on apatient comprised of: an inner cast member, where the inner cast allowsfor selected areas of the inner cast to accommodate anatomicalprotrusions or requirements associated with a patient's anatomy, wherethe inner cast member is molded and laced, and replicates properties ofan at least one portion of the patient's anatomy, an outer cast member,where the outer cast member is comprised of attachment points on saidouter cast member, and where the outer cast member contains an at leastone hook and loop fastener strap for securing the outer cast memberaround the inner cast member, and where the inner cast member iscomprised of a fiberglass reinforced plastic material that is heated atapproximately 325 degrees for two minutes, removing the material whilehot, draping the material on a positive mold of a patient's anatomy,vacuuming, the material to the positive mold, hardening forapproximately seven to ten minutes, and applying any required incisions.2. The system of claim 1 where the outer cast member contains two bandsof hook and loop fastening to secure the outer cast member around theinner cast member and provides support to the patient.
 3. The system ofclaim 2 where an outer shell further comprises an at least one cut awayfor allowing protrusions and for reducing a risk of negative pressure,and for allowing an inner shell to at least partially protrude throughthe outer shell.
 4. The system of claim 1 where the inner cast membercontains a fastener to secure the inner cast member, the fastenerselected from the group of an at least one hook and loop fastener, an atleast one zipper, an at least one button snap, magnets, and laces. 5.The system of claim 1 where an outer cast member is comprised of amaterial selected from the group of copolymer, polypropylene,polypropylene and ethylene, and plastic resin, the member s heated atapproximately 400 degrees Fahrenheit, the member s draped over apositive patient mold and allowed to sit for approximately one hour tomature, and applying cuts and modifications to the outer cast member. 6.The system of claim 5 where the heating lasts for between three and fiveminutes for a predetermined amount of hardness or softness.
 7. Thesystem of claim 1 where the at least one hook and loop fastener strap isa mid- to high-ankle strap for horizontal circumferential security of anouter shell around an inner shell.
 8. The system of claim 7 furthercomprising an at least one second strap that follows below the footarch, across the midfoot to anterior ankle area, and securescircumferentially at a horizontal plane above the lateral to medialankle area.
 9. The system of claim 1, where a system's inner and outermembers are made of a thermoplastic material formed in part by applyinga vacuum to said heated thermoplastic material to pull saidthermoplastic material tightly about the inner and outer member stockingmaterial, cooling a resulting vacuumed formed thermoplastic material,and cutting away a custom leg portion and a custom foot portion.
 10. Thesystem creating an orthotic brace of claim 1, where the brace is usedfor athletic support, and the brace comprises an outer shell of widthselected from the group of 5/32 inches, 3/16 inches, ¼ inches, ⅜ inches,and ½ inches, and where the brace limits dorsiflexion and planarflexion.
 11. The orthotic brace of claim 1, where an outer shell isfurther comprised of a fastener selected from the group of hook and loopfasteners, laces, buttons, an at least one zipper, or an at least onebutton snap.
 12. The orthotic brace of claim 1, where an at least onestrap is comprised of a first ankle support strap that is affixed to oneside of an upper ankle area of an outer shell member for withstandinghigh tension, and a second strap that is affixed to the outer shellmember that winds about the outer shell member from a patient's midfootand mid-ankle area to a posterior of a patient's ankle in a horizontalplane, continues to an opposite side of the same plane, to an areaacross a gap in the outer shell, and then the second strap proceedsacross an area approximately between the lower midfoot and Lisfranc'sJoint areas of the patient's anatomy, underneath a middle of a sole toprovide support to the lateral plantar, medial planter, and saphenousareas, with added support to the tibial and sural areas, and thenproceeds back across the area between the midfoot and Lisfranc's Jointareas and affixes at approximately the area where the strap began. 13.The orthotic brace of claim 12, further comprising removal of medialankle and heel sections.
 14. The orthotic brace of claim 1, furthercomprising stainless steel rivets for affixing an at least one strap,eyelets, and laces.
 15. The orthotic brace of claim 1, where theorthotic brace is a foot and ankle orthotic, and where a patient's moldis fabricated at an approximately 90-degree angle.
 16. The orthoticbrace of claim 1, where the orthotic brace is a foot and ankle orthotic,and where the mold is customized for a swing phase to result in a strikeat the midfoot.
 17. An orthotic brace comprised of an inner shell thatis molded and laced for at least partially surrounding a wearer's foot;an outer shell that receives the inner shell; at least one mid- tohigh-ankle strap for horizontal circumferential security of the outershell around the inner shell; an at least one second strap that proceedsbelow the wearer's foot arch, across a midfoot to anterior ankle area,to secure circumferentially above a lateral to medial ankle area andwhere the inner cast member is comprised of a fiberglass reinforcedplastic material that is heated at approximately 325 degrees for twominutes, removing the material while hot, draping the material on apositive mold of a patient's anatomy, vacuuming the material to thepositive mold, hardening for approximately seven to ten minutes, andapplying any required incisions.
 18. The orthotic brace of claim 17where the inner shell is further comprised of laces for securing theinner shell.
 19. The orthotic brace of claim 17 where an at least onesection of the outer shell is removed to allow for inner shell to expandthrough an area selected from a group of medial ankle area, heel, andlateral ankle area.
 20. The orthotic brace of claim 17, where the innershell extends above a patient's knee.
 21. The orthotic brace of claim17, where the inner shell rises to a patient's low ankle area.